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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S7-3T; TRANSDUCER, ULTRASONIC, DIAGNOSTIC
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S7-3T; TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number TRANSDUCER S7-3T
Device Problem Mechanical Jam (2983)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2020
Event Type  malfunction  
Manufacturer Narrative
Return of the suspect transducer is anticipated.Evaluation of the transducer will be included in a follow up report upon its return and investigation completion.
 
Event Description
A customer reported an s7-3t model transducer had an articulation issue during use.There was no injury associated with this event.
 
Manufacturer Narrative
A field service engineer replaced the suspect transducer for the customer to resolve the articulation issue.The suspect transducer was inadvertently scrapped prior to returning to philips for evaluation.Therefore, no failure or root cause analysis of the part could be performed.However, the ultrasound system has been returned to service with a replacement transducer with no similar issues reported.Device discarded.
 
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Brand Name
S7-3T
Type of Device
TRANSDUCER, ULTRASONIC, DIAGNOSTIC
MDR Report Key11197935
MDR Text Key228481879
Report Number3019216-2021-00011
Device Sequence Number1
Product Code ITX
UDI-Device Identifier00884838067530
UDI-Public00884838067530
Combination Product (y/n)N
PMA/PMN Number
K130499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberTRANSDUCER S7-3T
Device Catalogue Number989605439232
Was Device Available for Evaluation? No
Distributor Facility Aware Date12/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/11/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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